The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere's Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere's Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.

Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months).

Active Comparator: Active Arm

Treatment with 3 months of active drug

Drug: Famciclovir

Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug).

Other Name: Famvir

Eligibility

Ages Eligible for Study:

18 Years to 90 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Unilateral Meniere's Disease

2 vertigo episodes of at least 20 minutes

Fluctuating hearing by subjective history and/or audiometric documentation. Audiometric documentation is defined as affected ear pure-tone average change from an audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.

Less than 45 dB 4-frequency pure-tone average in the affected ear

Tinnitus and/or aural fullness

Willing to undergo the clinical trial procedures

Signed informed consent

Exclusion Criteria:

Acute or chronic middle ear disease in either ear

Only hearing ear

4-frequency pure-tone average > 45 dB in either ear

Known allergy to famciclovir or any of the ingredients in the formulation

Taking oral steroids or receiving IT steroids at time of enrollment. If the subject has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of treatment in the study

Must not have had previous inner ear surgery

History of immunodeficiency diseases such as HIV

History of renal insufficiency or other kidney diseases

A female of child-bearing potential who is pregnant

History of noncompliance to medical regimens

Unwilling to or unable to comply with the protocol, including scheduling study evaluations

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526408